Evaluation of Etanercept in Patients With Plaque Psoriasis After Stopping Ciclosporin Therapy

Pfizer120 enrolled

Overview

The purpose of this study is to evaluate the use of etanercept as a replacement therapy for ciclosporin in patients with plaque psoriasis.

The purpose of this study is to evaluate the efficacy and safety of etanercept as a replacement therapy for ciclosporin in patients with moderate to severe plaque psoriasis who have achieved an adequate response with ciclosporin.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Psoriasis

Interventions

EtanerceptDRUG

Etanercept 50 mg QW initiated during taper of ciclosporin

PlaceboOTHER

Randomized to placebo during taper of ciclosporin

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Between age 18 and 70 years * Active and stable plaque psoriasis with a BSA≥10 or PASI≥10. Exclusion Criteria: * Evidence of skin conditions other than psoriasis * Psoralen plus psoralen + ultraviolet A (PUVA), ciclosporin, acitretin, alefacept, anakinra, or any other systemic anti-psoriasis therapy or disease-modifying antirheumatic drugs (DMARD) with 28 days of screening * ultraviolet B (UVB) therapy, topical steroids, topical Vitamin A or D analog preparations, or anthralin * Prior exposure to any TNF-inhibitor. Prior exposure to efalizumab * Corticosteroid dose of prednisone \>10 mg/day * Serious infection * Receipt of any live vaccine * Abnormal hematology or chemistry * Body mass index (BMI) \> 38 * Pregnancy or Breastfeeding * Significant concurrent medical conditions

Outcomes

Primary Outcomes

Change From Randomization in PASI Score to Week 24 (Week 18 of Etanercept Monotherapy/Placebo)

PASI score: range: 0 (none) to 72 (maximum). Body was divided into head, upper extremities, trunk and lower extremities; each area score was combined for final PASI. For each section, percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: (erythema, induration, and desquamation); scale: 0 (none) to 4 (maximum). Final PASI= sum of severity parameters for each section times area score times weight of section (head: 0.1, upper extremities: 0.2, trunk: 0.3, lower extremities: 0.4). Change = PASI at Week 24 - PASI at baseline.

Time frame: Randomization to Week 24.

Secondary Outcomes

PASI Area Under the Curve (AUC) Between Randomization and Week 24

PASI AUC = Area under the curve from randomization (Week 6) to Week 24.

Time frame: Randomization to Week 24.

Change From Randomization in PGA Score to Week 24

PGA score is based on dermatologist's assessment of disease averaged over all lesions. Overall lesions were graded for individual scores of induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Change = PGA at Week 24 - PGA at baseline.

Time frame: Randomization to Week 24.

Relapse (Loss of 50% Improvement in PASI) During the 24 Weeks After Randomization

Relapse was defined as the loss of 50% improvement in PASI.

Time frame: Randomization to Week 24.

Probability of Being Relapse Free During the 24 Weeks After Randomization

Relapse was defined as loss of 50% improvement in PASI. The time to relapse was estimated using a Kaplan-Meier analysis.

Data from ClinicalTrials.gov

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